All documents shown here are included in the seminar for instant download

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for
instant download. All reference material as listed below and more is
available on a special seminar website. The website is regularly
updated with most recent information. In case there are questions
related to the topic, they can be submitted through a web form and
will be answered by the speaker. For ordering info
click here.

On-line Audio Seminar 119

Eight Steps for Cost-effective Software
and Computer System Validation

Get 10 most important documents for free:
SOPs, Checklists, Validation protocols

Recorded

While validating processes and equipment is well understood by people in the
regulated industries software still confuses people, despite of a 20 year
history and availability of guidance from industry and the FDA. The result is an
increasing number of FDA 483 form inspectional observations and warning letters
in this area.

Key Questions related to software and computer validation are:

How to develop a computer validation master plan?

What is the level of detail of user requirement and
functional specifications?

How to qualify the supplier: when is a vendor audit a must?

What and how much to test at installation?

I have multiple installations with the same configurations,
should I test all of them or is one enough?

How to document functional testing - when do I need to make
screen captures?

How to initiate and document changes to my computer system?

How to validate networks and Excel?

How to validate existing (legacy) systems?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will go
through all validation phases and give practical recommendations.
After the seminar, an extensive list of reference material like
SOPs, templates and examples will help immediate and cost effective
implementation.

How to order

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.